Deibel Laboratories of Illinois, Inc. – FDA Warning Letter, Apr 21, 2011

This FDA Warning Letter, issued to Deibel Laboratories of Illinois, Inc. on October 20, 2011, details significant Current Good Manufacturing Practice (CGMP) violations observed during an inspection from February 23 to April 21, 2011. These violations render the firm's drug products adulterated under Section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act.

Key violations include: 1. **Failure to conduct appropriate microbiological method suitability testing** for drug products (e.g., Chlorhexidine Gluconate, Levothyroxine Sodium), as per USP Chapters <61> and <62>, to ensure test methods can detect microorganisms. The firm's response, making validation client-discretionary, was deemed inadequate. 2. **Failure to establish and document accuracy, sensitivity, specificity, and reproducibility of test methods**, including lack of validation studies for analytical methods (e.g., PCMX Assay, Capsaicin Assay) and incomplete validation for others (e.g., Hydroquinone, Lidocaine Hydrochloride). The firm's proposed June 2012 completion date for validation was inadequate without interim reliability actions. 3. **Failure to verify suitability of all testing methods under actual conditions of use** (e.g., Tolnaftate USP Assay, Zinc Pyrithione by AA), with similar inadequacy in the firm'